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On March 5, 2025, the Federal Circuit affirmed the grant of a preliminary injunction against the launch of Celltrion’s proposed EYLEA® (aflibercept) biosimilar CT-P42 in CAFC Case Nos. 24-2058 and 24-2147 (appealing from...more
Completing a recent jurisprudential "hat trick,"* the Federal Circuit affirmed a District Court grant of a preliminary injunction against a biosimilar applicant for Regeneron's EYLEA biologic drug in Regeneron...more
On March 5, 2025, the U.S. Court of Appeals for the Federal Circuit affirmed the District Court for the Northern District of West Virginia’s entry of a preliminary injunction preventing Celltrion, Inc. (“Celltrion”) from...more
In this edition of The Precedent, we outline the decision in Regeneron Pharms., Inc. v. Mylan Pharms. Inc. In Regeneron Pharms., Inc. v. Mylan Pharms. Inc., the Federal Circuit affirmed the district court’s grant of a...more
On 25 February, the Court of Justice of the European Union (CJEU) issued its much-anticipated decision in BSH Hausgeräte v. Electrolux (C-339/22) on cross-border competence in patent litigation. At the heart of the dispute is...more
Note: This post addresses two Federal Circuit decisions issued on January 29, 2025. Both appeals involved Plaintiff-Appellee Regeneron Pharmaceuticals, Inc., with the first appeal involving Defendant-Appellant Formycon AG...more
Apple Inc., et al. v. Gesture Technology Partners, LLC, Nos. 2023-1501, -1554 (Fed. Cir. (PTAB) Jan. 27, 2025). Opinion by Dyk, joined by Lourie and Hughes....more
On January 29, 2025, the CAFC issued opinions affirming the preliminary injunctions issued against biosimilars of Regeneron’s EYLEA® (aflibercept): Samsung Bioepis’s Opuviz™ (aflibercept-yszy) (CAFC Case Nos. 24-1965,...more
Nearly two years in, the Unified Patent Court (UPC) continues to reshape the patent litigation landscape in Europe by providing swift, cross-border resolutions and an innovative approach to patent enforcement and revocation....more
In Natera Inc. v. NeoGenomics Laboratories, Inc. the Federal Circuit affirmed the District Court's grant of a preliminary injunction against NeoGenomics in patent infringement litigation involving Natera's U.S. Patent Nos....more
Late last week in Natera, Inc. v. NeoGenomics Laboratories, Inc. (24-1324), the Federal Circuit affirmed a preliminary injunction ruling from the lower court that mostly prohibits NeoGenomics from selling its oncology test...more
Nippon Shinyaku and Sarepta entered into a Mutual Confidentiality Agreement to facilitate discussions about a potential business relationship related to muscular dystrophy therapies. Section 6.1 of the MCA contained a mutual...more
As part of the recovery from the global COVID-19 pandemic, the U.S. Court of Appeals for the Federal Circuit took steps to return to normal operations. It began requiring live oral arguments in August 2022 and, by November,...more
The US Court of Appeals for the Federal Circuit affirmed the grant of a preliminary injunction, finding that the district court did not abuse its discretion, clearly err in its underlying factual findings or abuse its...more
Adapt Pharma Operations Limited v. Teva Pharmaceuticals USA, Inc., Appeal No. 2020-2106 (Fed. Cir. Feb. 10, 2022) - In our Case of the Week, the Court of Appeals for the Federal Circuit, in both the majority opinion and...more
In a recent judgment from The Court of Justice of the European Union (the “CJEU”) in case C-688/17, the CJEU had the chance to provide an interpretation of adequate compensation contained in article 9(7) of Directive 2004/48...more
Mere Potential for Future Appeal Does Not Prevent Triggering Estoppel of Inter Partes Reexamination When Party Fails to Seek Relief in the First Instance - In Virnetx Inc. v. Apple Inc., Appeal Nos. 2017-1591, -1592,...more
Arbitration - Waymo v. Uber Technologies, 870 F.3d 1342 (Fed. Cir. 2017) - Waymo sued Uber and others for trade secret misappropriation and patent infringement. Uber contends that Waymo should be compelled to...more
Since the Biologics Price Competition and Innovation Act of 2009 (BPCIA) was signed into law in 2010, only a small handful of abbreviated Biologics Licensing Applications (“aBLAs”) have been filed and of those the FDA has...more
Amgen Inc. v. Apotex Inc. (No. 2016-1308, 7/5/16) (Wallach, Bryson, Taranto) - July 5, 2016 12:05 PM - Taranto, J. In a suit under the Biologics Price Competition and Innovation Act, affirming the grant of a...more
Pre-AIA and Post-AIA Issues Presented by the On-Sale Bar - The “on-sale” bar to patentability refers to a sale or offer for sale of an invention that can invalidate the patent for that invention. The...more
The District Court for the District of Massachusetts (Judge Wolf) recently decided two pending motions in Janssen v. Celltrion: - ..Plaintiffs’ motion to stay litigation on the ‘471 patent (covering infliximab) pending...more
On Friday, June 12, 2015, the Federal Circuit issued its decision in Ariosa Diagnostics, Inc. v. Sequenom, Inc., affirming the district court's finding that Sequenom’s claims are invalid under 35 USC § 101. The court's...more